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Medical Devices

The development, manufacturing, and marketing of a medical device require an in-depth understanding of the FDA regulatory process, as well as the ability to interact effectively with FDA personnel. At OFW Law, our attorneys provide comprehensive counseling and advocacy on FDA medical device matters, ranging from product clearance and approval to postmarket requirements and enforcement/compliance issues, product promotion, and advertising issues.

Depth and Breadth of Expertise

At OFW Law, our attorneys understand the FDA regulatory process. Our medical device attorneys advise clients on a broad range of FDA medical device issues, including:

  • Litigation matters, such as
    • Civil penalty proceedings
    • Criminal prosecutions
    • Injunctions
    • Product seizures
    • Expert witness assistance
    • Lanham Act issues

  • Development of strategies to bring medical devices to market, pre-submission advocacy with key FDA officials, and preparation of necessary regulatory filings, such as:
    • Investigational Device Exemption (IDE) applications
    • Premarket Approval Applications (PMAs)
    • Premarket Notification Submissions (510(k)s)
    • Humanitarian Device Exemptions (HDEs)

  • Compliance with Medical Device Reporting (MDR) requirements, including employee education and system audits

  • Classification and reclassification of medical devices

  • Compliance with Quality System Regulation (QSR) requirements, including employee education and system audits

  • Pre- and post-distribution issues regarding the labeling, advertising, and promotion of medical devices

  • Highly specialized medical device regulatory matters, such as:
    • Medical software
    • Combination product
    • Custom devices

  • Managing risks associated with and responding to FDA enforcement actions

  • Preparing for and managing FDA inspections, including:
    • Conducting pre-inspection audits
    • Assisting during inspections
    • Drafting responses to Form FDA 483 inspectional observations

  • Conducting product recalls and other field actions

  • Medical device listing and establishment registration requirements

  • Medical device import and export issues, such as:
    • Export of unapproved devices
    • Import detentions
    • Import for export
    • Re-importation

  • Matters concerning clinical trials, such as:
    • Compliance with clinical trial requirements
    • Investigator disqualifications

Legislative Advocacy

At OFW Law, our attorneys are experienced participants in the legislative process and have played a key role in the enactment of seminal medical device legislation, including the Safe Medical Devices Act of 1990, the Medical Device User Fee and Modernization Act of 2002, and the Medical Device User Fee Stabilization Act of 2005.

Due Diligence, SEC, and Litigation Support

Our attorneys are an important resource for other law firms, investment bankers, venture capitalists, accountants, and other professionals engaged in matters requiring expertise in FDA medical device law and regulation. Our lawyers are frequently retained to assist with due diligence evaluations of medical device companies, and to provide advice on contractual language for mergers and acquisitions involving medical device firms. In addition, we are often called upon to provide litigation support in lawsuits involving FDA medical device issues. Moreover, our attorneys often assist with the formulation and preparation of FDA-related disclosures and statements for Securities and Exchange Commission (SEC) filings for medical device firms.

Medical Device Attorneys:

Medical Device Seminars:

Interacting and Avoiding Problems With the FDA

Interacting and Avoiding Problems with FDA (audio, part 1)

Interacting and Avoiding Problems with FDA (audio, part 2)